NCT04528810

Brief Summary

A comprehensive pediatric injury burden assessment is an essential foundation for formulating injury prevention strategies and improving emergency care for injured children. Although the hospital-based passive surveillance of national injury surveillance system of medical and health institutions has been well-established in China, the monitoring points of hospitals were not stratified according to children's hospital. Aim of the project is to collect epidemiological and clinical data to describe causes, clinical features and outcomes of pediatric injuries at a Children's Hospital in Shanghai, China. The project intends to establish a method for collecting and analyzing high quality data of child injury using data mining based on the hospital information system.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,762

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Jul 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Jul 2025Jul 2027

First Submitted

Initial submission to the registry

August 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
4.8 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

August 25, 2020

Last Update Submit

February 16, 2025

Conditions

Keywords

InjuriesChildEpidemiology

Outcome Measures

Primary Outcomes (1)

  • Distribution of injury categories

    According to the electronic medical record system, the distribution of injury categories is defined as the proportion of various injury causes (fall,motor vehicle crash,sports, struck, foreign body) in the cohort subjects.

    At baseline

Secondary Outcomes (4)

  • 28 days mortality

    Within 28 days from ED admission

  • 180 days mortality

    Within 180 days from ED admission

  • Short-term disability

    At 180 days from ED admission

  • Percentage of ICU admission

    From ED admission to 72 hours

Study Arms (1)

Child injuries

pediatric patients under the age of 18 years newly diagnosed with injuries in the emergency department

Other: not applicable (Observational Study)

Interventions

This is an observational study and does not include interventions.

Child injuries

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

pediatric patients between the ages of 0-18 years newly diagnosed with injuries

You may qualify if:

  • All pediatric patients between the ages of 0-18 years newly diagnosed with injuries in the emergency department,and recorded ICD-10 diagnosis codes from V01 to X39

You may not qualify if:

  • Patients who were dead on arrival to the emergency department are not included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 27, 2020

Study Start

July 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

February 18, 2025

Record last verified: 2025-02